(335 days)
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components, image processing, or data training/testing.
No
The device is described as an electrosurgical device intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, which makes it a surgical tool rather than a therapeutic device.
No
The device is described as an electrosurgical device intended for electrocoagulation and hemostasis, which are therapeutic procedures, not diagnostic ones. The performance studies also focus on tissue damage profiles and treatment effects, not diagnostic accuracy.
No
The device description explicitly lists multiple hardware components including a generator, footswitch, handpiece, gas cylinder, and other physical parts, indicating it is not software-only.
Based on the provided information, the Agelet system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis" in "dermatologic and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The description details an "electrosurgical device" with components like a generator, handpiece, and footswitch. These are typical components of surgical equipment used for tissue manipulation and treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process related to diagnosing or monitoring a disease or condition based on in vitro analysis.
- Performance Studies: The performance studies describe "in vitro testing... performed on four different types of tissue" to assess "thermal damage profiles." While this uses the term "in vitro," it refers to testing the device's effect on excised tissue samples, not a diagnostic test performed on patient samples for clinical diagnosis.
In summary, the Agelet system is a surgical device used for treating tissue, not a diagnostic device used for analyzing samples to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
The Agelet system is an electrosurgical device and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AgeJet system is an electro-surgical device intended for use in dermatological applications in hospital and clinics.
The AgeJet system comprises of the following.
AgeJet Generator
The wheeled unit powered by120 VAC (available 110-240 VAC according to the market) with standard wall socket.
Footswitch
This is a single pedal type for activation of the output.
Handpiece/Cable Assembly
The handpiece and the cable assembled can be easily plugged and unplugged from the AgeJet Generator as reported in the User Manual. The handpiece has an integral key that is used by the generator to ensure it is not used beyond its operational life.
Handpiece holder
The handpiece holder with the thermal sensor is connected to the generator according to the User Manual.
Procedure Pack
Comprising one or more disposable nozzles that is connected to the handpiece, and which have an integral key that is used by the generator to ensure it is not used beyond its operational life.
Nitrogen Gas Cylinder & Pressure regulator
These are not supplied as a part of the AqeJet system. Only medical grade nitrogen (99.5% purity) should be used. The Nitrogen tank is specified as 534mm high by 106mm diameter, a capacity of 560 litres at 2200psiG.
Cylinder Holder Plate Kit
This kit includes screws, plate, cable holder shaft and cable tray. Please refer to the User Manual for the installation procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatological applications in hospital and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to assess the performance characteristics of AgeJet and ensure its functionality and stability when used in accordance with the manufacturer indications. The device was tested to verify that the output power value falls within the manufacturers specified range, thus ensuring the efficiency of the device. The results show that AgeJet works as expected, according to the manufacturers specifications.
In vitro testing of the AgeJET nitrogen plasma device was performed on four different types of tissue as per Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (DOC-FDA-2014-D-0217): liver, kidney, muscle, and skin. Treatment settings included the three power levels, low (1 J), medium (2 J) and maximum (4 J), at the minimum clinically relevant distance (5 mm) from the tissue surface and at temperature close to physiological 37°C. All test settings were triplicated and collected biopsy samples analyzed by H&E histology method. The testing demonstrated that the treatments produced clearly detectable thermal damage profiles in treated tissues with depths ranging from a few tens of microns up to a few hundred microns for a sinqle pulse treatment and several stacked pulses, respectively. The study demonstrated the ability of the AgeJet device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate device. Thus, it can be concluded that treatment by such device at the appropriate testing settings will possess a desirable clinical treatment effect.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
July 7, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Triworks Group SRL % Matthew Brulport President NEOconcepts LLC 2773 Alum Crossing Dr. Lewis Center, Ohio 43035
Re: K212472
Trade/Device Name: AgeJet Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 17, 2022 Received: June 21, 2022
Dear Matthew Brulport:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical
1
device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212472
Device Name AgeJet System
Indications for Use (Describe)
The Agelet system is an electrosurgical device and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K212472. 510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
| Submitter's Name: | Lorenzo Berchicci |
|---|---|
| Company: | Triworks Group srl |
| Submitter's Address: | via Leone Belpulsi, 3 - 86100 Campobasso (CB) Operational |
| Office: via Don Giuseppe Mucciardi, 5 86020 Campochiaro | |
| (CB) - Italy. | |
| Phone: | +39 0874 1896435 |
| Fax: | +39 0874 1896435 |
| Email: | Lorenzo Berchicci 1.berchicci@triworks.it |
| Date Prepared: | July 4th 2022 |
| Device Trade Name: | AgeJet |
Device Common name: Electrosurgical Device
Device Classification Information:
| Regulation
Number | Device
Classification
name | Device
Class | Product
Code | Classification
Panel | Type |
|----------------------|-------------------------------------------------------------------------|-----------------|-----------------|------------------------------|------------------------|
| 21 CFR
878.4400 | Electrosurgical
cutting and
coagulation device
and accessories | Class 2 | GEI | General &
Plastic Surgery | Traditional
510 (k) |
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Device Description
The AgeJet system is an electro-surgical device intended for use in dermatological applications in hospital and clinics.
The AgeJet system comprises of the following.
AgeJet Generator
The wheeled unit powered by120 VAC (available 110-240 VAC according to the market) with standard wall socket.
Footswitch
This is a single pedal type for activation of the output.
Handpiece/Cable Assembly
The handpiece and the cable assembled can be easily plugged and unplugged from the AgeJet Generator as reported in the User Manual. The handpiece has an integral key that is used by the generator to ensure it is not used beyond its operational life.
Handpiece holder
The handpiece holder with the thermal sensor is connected to the generator according to the User Manual.
Procedure Pack
Comprising one or more disposable nozzles that is connected to the handpiece, and which have an integral key that is used by the generator to ensure it is not used beyond its operational life.
Nitrogen Gas Cylinder & Pressure regulator
These are not supplied as a part of the AqeJet system. Only medical grade nitrogen (99.5% purity) should be used. The Nitrogen tank is specified as 534mm high by 106mm diameter, a capacity of 560 litres at 2200psiG.
Cylinder Holder Plate Kit
This kit includes screws, plate, cable holder shaft and cable tray. Please refer to the User Manual for the installation procedures.
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Intended Use
The AgeJet system is an electrosurgical device used in dermatologic and general surgical for electro coagulation and hemostasis.
Plasma energy is delivered to the tissue and energy is rapidly transferred to the tissue surface. As the plasma energy passes through the tissue it generates an electrothermal reaction which is capable of coagulating tissue.
Indications for Use
The AgeJet system is an electrosurgical device that can be used in the treatment of dermatological and general surgical conditions through electro coagulation and hemostasis.
Predicate device(s)
The AgeJet system is substantially equivalent to the PlaDuo system K201735.The AgeJet system is predicated against Pladuo as both devices are electrosurgical devices intended for the treatment of dermatological and general surgical conditions through electro coagulation and hemostasis.
The key technological characteristics of the subject device and predicate device are summarized in the following table;
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| Characteristics | Proposed device
AgeJet Device
K212472 | PlaDuo System
K201735 | Degree of equivalence |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Manufacturer name &
address. | Triworks SRL
Via S. Rocco, 58 Bis
86037
Palata CB
Italy | SheNB Co Ltd
Seongsui-ro,
148 Seongdong-gu
Seoul
South Korea | N/A |
| Device Trade Name | AgeJet | PlaDuo | N/A |
| Mode of Operation | Nitrogen Gas | Nitrogen Gas | Identical |
| Intended use | An electrosurgical device used in
dermatologic and general surgical
for electro coagulation and
hemostasis. | An electrosurgical device used in
dermatologic and general surgical
for electro coagulation and
hemostasis. | Identical |
| Principle of Operation | Plasma energy is delivered to the
skin and the energy is rapidly
transferred to the skin surface.
As the plasma energy passes
through the tissue it generates
an electrothermal reaction which
is capable of coagulating tissue. | Plasma energy is delivered to the
skin and the energy is rapidly
transferred to the skin surface. As
the plasma energy passes through
the tissue it generates an
electrothermal reaction which is
capable of coagulating tissue. | Identical |
| Frequency | 2.45Ghz | 2.45Ghz | Identical |
| Modulation | Pulsed Carrier wave | Pulsed Carrier Wave | Identical |
| Max Power (w) overall | 260W
(260-160 = 100W) | 100W | Identical |
| Cooling compressor
power (W) | 160W | Not Applicable | PlaDuo does not have patient
cooling system |
| Maximum Magnetron
output | 900W
(AgeJet uses only 11% of total at
all energy levels) | Not known | - |
| Output Energy (joule) | 0.5-41 | 4 | Identical |
| Characteristics | Proposed device
AgeJet Device
K212472 | PlaDuo System
K201735 | Degree of equivalence |
| Repetition rate | 1-3 Hz | 1-3Hz | Identical |
| Pulse Width (single
pulse) | 4 to 15ms | 5 to 15ms | Equivalent |
| Depth of Thermal
effect | Up to 350 microns | Up to 400 microns | Equivalent |
| Gas requirement | Medical grade Nitrogen 99.9% | Medical grade Nitrogen 99.9% | Identical |
| Electrical supply
Voltage | AC 110 - 240 Volts
50/60 Hz | AC 100 - 230 Volts
50/60 Hz | Equivalent |
| Mains connection | Detachable Power Cord to IEC
type appliance inlet
Mains Switch controlled ON/OFF
Operation | Detachable Power Cord to IEC
type appliance inlet
Mains Switch controlled ON/OFF
Operation | Identical |
| Device classification | Class II | Class II | Identical |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical |
| Rx/OTC | RX | RX | Identical |
| Device classification
name | Electrosurgical cutting and
coagulation device and
accessories | Electrosurgical cutting and
coagulation device and
accessories | Identical |
| Device product code,
classification name | GEI | GEI | Identical |
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Similarities and Differences between the subject and predicate device: Key Similarities
The AgeJet system is substantially equivalent to the PlaDuo System (K201735), as both are electrosurgical devices used in dermatologic and general surgical for electro coagulation and hemostasis.
Both systems exact their effect on the tissue through the same mechanism. Plasma energy is delivered to the skin and the energy is rapidly transferred to the skin surface. As the plasma energy passes through the tissue it generates an electrothermal reaction which is capable of coagulating tissue.
The AgeJet system and PlaDuo have the same principle of operation, mode of action and equivalent energy outputs to a maximum of 4Joule.
Both devices have similar incremental precision settings of 0.25J and 0.1 Joule respectively.
The AgeJet, and PlaDuo systems have identical treatment pulse repetition rates 1.0 to 3.0 Hz.
The pulse of UHF required to generate a given energy level or single Pulse width are equivalent.
The RF output frequency of the proposed device is identical to the predicate device 2.45Ghz.
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Differences
There are no significant differences in terms of the key device parameters that raise questions in terms of safety and efficacy.
Where there are differences between the AgeJet system and the predicate device, these occur in terms of the devices services which do not alter efficacy parameters of the device and where necessary have been tested and conform to relevant standards.
Electrical safety and safety standards
To demonstrate safety and effectiveness of the AgeJet system and to demonstrate substantial equivalence to the predicate devices, Triworks Group srl has completed several non-clinical performance tests. The AgeJet meets established requirements for overall design, electrical safety, software validation and usability studies confirming that the design outputs meet design input requirements and established specifications.
The AgeJet system successfully passed testing per internal verification/validation requirements and national/international standards illustrated below: EN 60601-1:2006 EN 60601-1-2:2015
EN 60601-2-2:2018
Other Non-Clinical Performance testing
To demonstrate safety and effectiveness and substantial equivalence the AgeJet system has undergone several non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, and software.
The following non-clinical performance data is provided in support of the substantial equivalence determination.
Biocompatibility
Materials used in the AgeJet system have been evaluated in respect to material composition, use and patient/user contact according to ISO 10993-1: 2018.
Software verification and validation testing
Software has been classified in accordance with EN 62304:2015 and Guidance for the Content of Premarket Submissions for Software Contained in Medical
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Image /page/10/Picture/1 description: The image shows the logo for TRIWORKS. The logo features a stylized trident symbol in gray, above the word "TRIWORKS" in a sans-serif font. Below the word, there are two horizontal bars in green and red, resembling the colors of the Italian flag. Underneath the bars, the tagline "The Intelligent Beauty" is written in a smaller, lighter gray font.
Devices Guidance for Industry and FDA Staff May 2005. Verification and Validation in accordance with the software risk concern provides evidence that all design specifications were met.
Performance testing
Performance tests were conducted to assess the performance characteristics of AgeJet and ensure its functionality and stability when used in accordance with the manufacturer indications. The device was tested to verify that the output power value falls within the manufacturers specified range, thus ensuring the efficiency of the device. The results show that AgeJet works as expected, according to the manufacturers specifications.
In vitro testing of the AgeJET nitrogen plasma device was performed on four different types of tissue as per Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (DOC-FDA-2014-D-0217): liver, kidney, muscle, and skin. Treatment settings included the three power levels, low (1 J), medium (2 J) and maximum (4 J), at the minimum clinically relevant distance (5 mm) from the tissue surface and at temperature close to physiological 37°C. All test settings were triplicated and collected biopsy samples analyzed by H&E histology method. The testing demonstrated that the treatments produced clearly detectable thermal damage profiles in treated tissues with depths ranging from a few tens of microns up to a few hundred microns for a sinqle pulse treatment and several stacked pulses, respectively. The study demonstrated the ability of the AgeJet device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate device. Thus, it can be concluded that treatment by such device at the appropriate testing settings will possess a desirable clinical treatment effect.
Statement of Substantial Equivalence:
513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and equivalent technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or non-clinical performance testing demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not
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raise any different questions of safety and effectiveness than the predicate device for the same intended use.
Triworks Group srl has demonstrated that the AgeJet device has the same intended use as the predicate device, employs equivalent technological characteristics, and has similar thermal effects in tissue. Where there are minor differences, these occur only in the basic services of the device. The sponsor demonstrates that the device does not pose any additional questions regarding safety and efficacy relative to the predicate.
Therefore, the AgeJet system, as designed, and manufactured, has been demonstrated to be substantially equivalent to the referenced predicate, the PlaDuo System K201735.